InfoCons Consumer Protection informs you – Exelon – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor , pharmacist or nurse .
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects , talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet . See section 4.

What is i n this leaflet 1. What Exelon is and what it is used for 2. What you need to know b efore you take Exelon 3. How to take Exelon 4. Possible side effects 5. How to store Exelon 6. Content s of the pack and other information 1. What Exelon is and what it is used for The active substance of Exelon is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylchol inesterase. By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease.

Exelon is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour . The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson’s disease.

2. What you need to know before you take Exelon

Do not take Exelon

• if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.

If this applies to you, tell your doctor and do not take Exelon.

94 Warnings and precautions Talk to your doctor before taking Exelon:

• if you have, or have ever had, a heart condition such as an irregular or slow heartbeat , QTc prolongation, a family history of QTc prolongation, torsade de pointes , or have a low blood level of potassium or magnesium .
• if you have, or have ever had, an active stomach ulcer.
• if you have, or have ever had, difficulties in passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or severe respiratory disease.
• if you have, or have ever had impaired kidney function.
• if you have, or have ever had, impaired liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea ), being sick (vomiting ) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged .

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

If you have not taken Exelon for more than three days, do not take the next dose until you have talked to your doctor.

Children and adolescents

There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Exelon

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.

Exelon should not be given at the same time as other medicines with similar effects to Exelon. Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Exelon should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst taking Exelon, tell your doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Exelon is taken together with beta -blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness .

Caution when Exelon is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation) .

Pregnancy , breast -feeding and fertility If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Exelon must be assessed against the possible effects on your unborn child. Exelon should not be used during pregnancy unless clearly necessary.

You should not breast -feed during treatment with Exelon.

95 Driving and using machines Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.

Exelon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.

3. How to take Exelon Always take this medicine exactly as your doctor has told you. Check with your doctor , pharmacist or nurse if you are not sure.

How to start treatment Your doctor will tell you what dose of Exelon to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose that should be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst you are taking this medicine.

If you have not taken Exelon for more than three days, do not take the next dose until you have talked to your doctor.

Taking this medicine

• Tell your caregiver that you are taking Exelon .
• To benefit from your medicine, take it every day.
• Take Exelon twice a day, in the morning and evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or crush the capsules.

If you take more Exelon than you should

If you accidentally take more Exelon than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressu re and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to take Exelon

If you find you have forgotten to take your dose of Exelon , wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may have side effects more often when you start your medicine or when your dose is increased.

Usually, the side effects will slowly go away as your body gets used to the medicine.

Very common (may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea 96 Common (may affect up to 1 in 10 people)
• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• Decreased appetite
• Nightmares
• Sleepiness

Uncommon (may affect up to 1 in 100 people)

• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working

Rare (may affect up to 1 in 1,000 people)

• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine

Very rare (may affect up to 1 in 10,000 people)

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with your heartbeat such as fast or slow heartbeat
• Bleeding in the gut – shows as blood in stools or when being sick
• Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements

Not known (frequency cannot be estimated from the available data)

• Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
• Dehydration (losing too much fluid)
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, t iredness and loss of appetite)
• Aggression , feeling restless
• Uneven heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side) Patients with dementia and Parkinson’s disease These patients have some side effects more often. They also have some additional side effects:

Very common (may affect more than 1 in 10 people)

• Trembling
• Accidentally falling

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness
• Seeing things that are not there (hallucinations)
• Depression
• High blood pressure

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements
• Low blood pressure

Not known (frequency cannot be estimated from the available data)

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
• Skin rash Other side effects seen with Exelon transdermal patches and which may occur with the hard capsules:

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known (frequency cannot be estimated from the available data)

• Allergic reaction where the patch was used, such as blisters or skin inflammation
• If you get any of these side effects, contact your doctor as you may need medical assistance.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Exelon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP . The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

98 6. Content s of the pack and other information

What Exelon contains

• The active substance is rivastigmine hydrogen tartrate.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172) , titanium dioxide (E171) and shellac .

Each Exelon 1.5 mg capsule contains 1.5 mg of rivastigmine.

Each Exelon 3.0 mg capsule contains 3.0 mg of rivastigmine.

Each Exelon 4.5 mg capsule contains 4.5 mg of rivastigmine.

Each Exelon 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Exelon looks like and contents of the pack

• Exelon 1.5 mg hard capsules, which contain an off -white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on the body.
• Exelon 3.0 mg hard capsules, which contain an off -white to slightly yellow powder, have an orange cap and orange body, with a red imprint “EXELON 3 mg” on the body.
• Exelon 4.5 mg hard capsules, which contain an off -white to slightly yellow powder, have a red cap and red body, with a white imprint “EXELON 4,5 mg” on the body.
• Exelon 6.0 mg hard capsules, which contain an off -white to slightly yellow powder, have a red cap and orange body, with a red imprint “EXELON 6 mg” on the body.

They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) but these may not all be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 Nuremberg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 99 България Novartis Bulgaria EOOD Тел: +359 2 489 98 28 Luxembourg/Luxemburg Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Česká republika Novartis s.r.o.

Tel: +420 225 775 111 Magyarország Novartis Hungária Kft.

Tel.: +36 1 457 65 00 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00 Malta Novartis Pharma Services Inc.

Tel: + 356 2122 2872 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V.

Tel: +31 88 04 52 111 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Norge Novartis Norge AS Tlf: +47 23 05 20 00 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00 Polska Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888 France Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00 Portugal Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600 Hrvatska Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220 România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Slovenija Novartis Pharma Services Inc.

Tel: +386 1 300 75 50 Ísland Vistor hf.

Sími : +354 535 7000 Slovenská republika Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu 101 Package leaflet: Information for the user Exelon 2 mg/ml oral solution rivastigmine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Exelon is and what it is used for

The active substance of Exelon is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).

Rivastigmine works by blocking the enzymes tha t break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helpin g to reduce the symptoms of Alzheimer’s disease.

Exelon is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour .

⚠️ 2. What you need to know before you use Exelon

Do not use Exelon

• if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives ).
• if you have a skin rea ction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.

If this applies to you, tell your doctor and do not apply Exelon transdermal patches.

Warnings and precautions

Talk to your doctor before using Exelon :

• if you have, or have ever had, a heart condition such as an irregular or slow heartbeat , QTc 111 prolongation, a family history of QTc prolongation, torsade de pointes , or have a low blood level of potassium or magnesium .
• if you have, or have ever had, an active stomach ulcer.
• if you have, or have ever had, difficulties in passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or a severe respiratory disease.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
• if you have impaired liver function.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor.

Children and adolescents

There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Exelon

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.

Exelon might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine ), to treat Parkinson’s disease (e.g. amantadine ) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine ).

Exelon Patch should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst using Exelon transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Exelon Patch is given together with beta -blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia ) leading to fainting or loss of consciousness .

Caution when Exelon is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation) .

Pregnancy , breast -feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Exelon must be assessed against the possible effects on your unborn child. Exelon should not be used during pregnancy unless clearly necessary.

You should not breast -feed during treatment with Exelon transdermal patches.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.

Exelon transdermal patches may cause fainting or severe confusion. If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.

💊 3. How to use Exelon

Always use Exelon transdermal patches exactly as your doctor has told you. Check with your doctor , pharmacist or nurse if you are not sure .

IMPORTANT:

• Take off the previous patch before putting ONE new patch on.
• Only one patch per day .
• Do not cut the patch into pieces.
• Press the patch firmly in place for at least 30 seconds using the palm of the hand.

How to start treatment Your doctor will tell you which Exelon transdermal patch is most suitable for you.

• Treatment usually starts with Exelon 4.6 mg/24 h.
• The recommended usual daily dose is Exelon 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
• Only wear one Exelon patch at a time and replace the patch with a new one after 24 hours.

During the course of the treatment your doctor may adjust the dose to suit your individual needs.

If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise your doctor will restart your treatment on Exelon 4.6 mg/24 h.

Exelon can be used with food, drink and alcohol.

Where to apply your Exelon transdermal patch

• Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
• Carefully remove any existing patch before putting on a new one. Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
• Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams:
• left upper arm or right upper arm
• left upper chest or right upper chest (avoid breast)
• left upper back or right upper back
• left lower back or right lower back 113 Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.

When changing the patch, you must remove the previous day’s patch before you apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day). Do not apply a new patch to th e same skin area twice within 14 days.

How to apply your Exelon transdermal patch Exelon patches are thin, opaque, plastic patches that stick to the skin. Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.

Carefully remove the existing patch before putting on a new one.

For patients starting treatment for the first time and for patients restarting Exelon after treatment interruption, please begin with the second picture.

• Each patch is sealed in its own protective sachet.

You should only open the sachet when you are ready to apply the patch.

Cut the sachet along the dotted line with scissors and remove the patch from the sachet.

Left or right upper arm Left or right side of chest Side Front Back Back Left or right upper back Left or right lower back OR OR OR OR 114 – A protective liner covers the sticky side of the patch.

Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.

• Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.
• Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.

If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.

The patch should be worn continuously until it is time to replace it with a new one. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.

How to remove your Exelon transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin. In case the adhesive residue is left over on your skin, gently soak the area with warm water and mild soap or use baby oil to remove it. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.

You should wash your h ands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Exelon transdermal patch when you are bathing, swimming, or in the sun?

• Bathing, swimming or showering should not affect the patch. Make sure the patch does not loosen during these activities.
• Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium) for long periods of time.

What to do if a patch falls off If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.

When and for how long to apply your Exelon transdermal patch

• To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
• Only wear one Exelon patch at a time and replace the patch with a new one after 24 hours.

If you use more Exelon than you should

If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch. You may require medical attention. Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and 115 fainting may also occur.

If you forget to use Exelon

If you find you have forgotten to apply a patch, apply one immediately. You may apply the next patch at the usual time the next day. Do not apply two patches to make up for the one that you missed.

If you stop using Exelon

Tell your doctor or pharmacist if you stop using the patch.

If you have any further questions on the use of this medicine , ask your doctor or pharmacist.

❗ 4. Possible side effects

Like all medicines, Exelon transdermal patches can cause side effects, although not everybody gets them.

You may have side effects more often when you start your medicine or when your dose is increased.

Usually, the side effects will slowly go away as your body gets used to the medicine.

Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Feeling dizzy
• Feeling agitated
• Urinary incontinence (inability to retain adequate urine)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
• Heartburn
• Stomach pain
• Rash
• Allergic reaction where the patch was used, such as blisters or inflamed skin
• Feeling tired or weak
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Problems with your heartbeat such as slow heartbeat
• Stomach ulcer
• Dehydration (losing too much fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggression

Rare (may affect up to 1 in 1 ,000 people)

• Falling

Very rare (may affect up to 1 in 10,000 people)

• Stiff arms or legs and trembling hands 116 Not known (frequency cannot be estimated from the available data)
• The signs of Parkinson’s disease get worse – such as tremor, stiffness and shuffling
• Inflammation of the pancreas – signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• Fast or uneven heartbeat
• High blood pressure
• Fits (seizures)
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, t iredness and loss of appetite)
• Changes in tests which show how well the liver is working
• Feeling restless
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Trembling
• Sleepiness
• Rash, i tching
• Skin reddening
• Blister s Take off your patch and tell your doctor straight away, if you notice any of the side effects above.

Other side effects seen with Exelon capsules or oral solution and which may occur with the patch:

Common (may affect up to 1 in 10 people)

• Too much saliva
• Feeling restless
• Generally feeling unwell
• Trembling
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Uneven heart rate (e.g. fast heart rate)
• Difficulty sleeping
• Accidental falls

Rare (may affect up to 1 in 1,000 people)

• Fits (seizures)
• Ulcer in the intestine
• Chest pain – this may be caused by heart spasm

Very rare (may affect up to 1 in 10,000 people)

• High blood pressure
• Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• Bleeding in the gut – shows as blood in stools or when being sick
• Seeing things that are not there (hallucinations)
• Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting 117 system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Exelon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP . The expiry date refers to the last day of th at month.
• Do not store above 25°C.
• Keep the transdermal patch in the sachet until use.
• Do not use any patch that is damaged or shows signs of tampering.
• After removing a patch, fold it in half with the sticky sides on the inside and press them together. Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch. Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment .

📦 6. Content s of the pack and other information

What Exelon contains

• The active substance is rivastigmine.
• Exelon 4.6 mg/24 h transdermal patches : Each patch releas ing 4.6 mg of rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.
• Exelon 9.5 mg/24 h transdermal patches : Each patch releas ing 9.5 mg of rivastigmine per 24 hours is 10 cm2 and contains 18 mg of rivastigmine.
• Exelon 13.3 mg/24 h transdermal patches : Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm2 and contains 27 mg of rivastigmine.
• The other ingredients are polyethylene terephthalate film lacquered, alpha -tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer -coated.

What Exelon looks like and contents of the pack

Each transdermal patch is a thin patch consisting of three layers. The outer layer is beige and labelled with the following:

• “Exelon”, “ 4.6 mg/24 h” and “AMCX”,
• “Exelon”, “ 9.5 mg/24 h” and “BHDI” ,
• “Exelon”, “13.3 mg/24 h” and “CNFU”.

One transdermal patch is sealed in one sachet.

Exelon 4.6 mg/24 h transdermal patches and Exelon 9.5 mg/24 h transdermal patches are available in packs containing 7, 30 or 42 sachets and in multipacks containing 60, 84 or 90 sachets.

Exelon 13.3 mg/24 h transdermal patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland 118 Manufacturer Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 Nuremberg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 България Novartis Bulgaria EOOD Тел: +359 2 489 98 28 Luxembourg/Luxemburg Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Česká republika Novartis s.r.o.

Tel: +420 225 775 111 Magyarország Novartis Hungária Kft.

Tel.: +36 1 457 65 00 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00 Malta Novartis Pharma Services Inc.

Tel: + 356 2122 2872 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V.

Tel: +31 88 04 52 111 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Norge Novartis Norge AS Tlf: +47 23 05 20 00 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00 Polska Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888 France Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00 Portugal Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600 119 Hrvatska Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220 România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Slovenija Novartis Pharma Services Inc.

Tel: +386 1 300 75 50 Ísland Vistor hf.

Sími : +354 535 7000 Slovenská republika Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Exelon (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/98/066).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.